Justify proposed dosage and high strength with data: CDSCO Panel Tells Hetero Healthcare on Tioconazole vaginal film 300 mg
New Delhi: Noting Tioconazole Vaginal Film 300mg is not approved anywhere in the world, the Subject Expert Committee SEC functional under the Central Drug Standard Control Organisation (CDSCO) has opined Hetero Healthcare to submit adequate rational/justification for the development of the proposed dosage form in such high strength along with release pattern data of the proposed formulation, adequate toxicity data, anticipated side effects, and supportive clinical evidence of the proposed dosage form to CDSCO for further review by the committee.
This came after Hetero Healthcare presented the proposal for manufacturing and marketing of Tioconazole Vaginal Film 300 mg along with Phase III protocol (Protocol No. HHCL/01-01/24 version 1.0 dated 18/01/2024) before the committee.
The committee noted that Tioconazole Vaginal Film 300mg is not approved anywhere in the world. However, Ticonazole vaginal gel 65mg/gm is approved in India on dated 22.03.2011. However, Ticonazole vaginal gel 65mg/gm is approved in India on dated 22.03.2011.
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